Clinical Quality and Compliance Lead

Ipsen•Cambridge, MA

10d•$135,000 - $165,000

About The Position

The Clinical Quality and Compliance Lead is a key role in the Clinical Development Operations function responsible to ensure ongoing compliance to appropriate Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines for all Ipsen Clinical Trials. He/she will ensure compliance in strong partnership with Head Site Management and Monitoring and TA Leads. The Clinical Quality and Compliance Lead should be able to work independently and be a strong communicator, leader and team player, with demonstrated ability as a quick learner and problem-solver. This role will Partner with Head Site Management and Monitoring and TA Leads to ensure ongoing compliance to appropriate Quality Standards, Standard Operating Procedures, Health Authority/Country Regulations and guidelines. The Clinical Quality and Compliance Lead should be able to work independently and be a strong communicator, leader and team player, with demonstrated ability as a quick learner and problem-solver contribute in building a Cluster quality plan that aligns the Global Quality priorities and initiatives and that will ensure IPSEN clinical trials are delivered to the highest quality standards and are following all applicable SOP's, laws and regulations. ensure the CDO team is adequately trained and onboarded. Our new colleague should be flexible and able to work independently. collaborate with the Cluster Head, the Clinical Project Managers and the wider study teams, carrying out the clinical trials, across both internal IPSEN/FSP to assure inspection readiness at all times and to be responsive in developing and monitoring effective implementation of CAPAs as a result of regulatory inspection be part of a hardworking, enthusiastic, and committed team eager to deliver and helping to improve the lives of millions of patients.

Requirements

A minimum of 8 years of previous Pharmaceutical Industry experience is required, with at least 5 years of GXP experience within clinical research and development and/or quality assurance.
Experience in Quality Control and Compliance, Quality Assurance, CAPA process and/or Root Cause Analysis.
Knowledge of the overall drug development process
Well-developed skills and knowledge of clinical operations business processes and practices (i.e., SOPs governing clinical research activities)
Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset
Planning and tracking skills, able to see the big picture, well organized, focused on results, customer focused, capable of managing multiple projects, excellent time management with respect to priorities and self-management.
Ability to motivate professional colleagues and stakeholders
Proven conflict resolution/management and negotiation skills
Ability to independently plan, organize, coordinate, manage and execute assigned tasks
Demonstrated clarity of communication
Demonstrated ability to influence key internal and external stakeholders
Experience of the key customers’ business processes and practices
Demonstrated ability to deliver a culture of continuous improvement
Demonstrated ability to engage with authorities, trade associations and key sites
Batchelors Degree in life sciences or a professional degree in life sciences (eg Nursing , Pharmacy)
Fluent in English

Nice To Haves

Experience across all Clinical Trial Phases 1-4 would be preferred
Experience in Oncology would be preferred
Project Management Certificate (PMP/PRINCE2 etc.)
Fluent in the languages for the countries to be supported at country/cluster level

Responsibilities

Contribute in building a long-term quality plan for the cluster(s), one that ensures high quality delivery of investigator sites and of IPSEN and FSP staff
proactively measure and identify compliance risks and define remediation actions to manage those risks (study and site level)
supervise progress and confirm effectiveness of remediation plans and conduct QC checks on trials and processes
Support Clinical Operations roles with quality issues that need to be captured in Quality /Risk Management System:
Liaise with investigation owner and CAPA Manager to identify appropriate CAPA owner (study specific vs. general/systemic issue)
Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the CAPA Manager
Assist the Investigation Owner and CAPA Manager in the application of structured problem‐solving methodologies in Root Cause Analysis (RCA) investigations in support of the Root Cause Investigation team
Support Clinical Operations issue owner on logistical aspects of issue resolution:
Identifying additional stakeholders if needed to support RCA investigation and resulting actions
support discussions with stakeholders
Keep oversight on CAPA milestones together with CAPA Manager
Timely escalate systemic issues identified during issue discussion to Head Site Management and Monitoring and to Global Quality/QA roles
Track quality issues with respect to timelines and affected areas/topics
Monitor audit and inspection announcements to ensure timely involvement of Medical and Clinical Operations SMEs in support of audit and inspection readiness
Support Global QA , Head of Site Management and Monitoring and/or TA Heads with document or data requests during internal audits and inspections by engaging appropriate SMEs across R&D
Support Global QA , Head of Site Management and Monitoring and/or TA Heads and/or responsible issue owner after audit and inspection on CAPA activities
Work closely with Global Quality to ensure Cluster Quality plans are aligned with Global Quality plans and risk assessments (study and site level)
Support CDO Leaders to identify appropriate SME to represent CDO for procedural document review/creation
Track ongoing procedural document review/creation activities for timely involvement and completion
Work with CDO leaders and cross-functional BPOs on relevant procedural document updates related to CAPA commitments
Be accountable for continuous improvement of CDO processes
Local regulatory intelligence: perform impact assessments of new/revised local regulations and provide clear and timely guidance to the teams. Keep local intelligence up to date.
Collaboration with business quality: perform local supplier assessments; coordinate annual due diligence update, certification and training of local suppliers.
As required, Leads and/or participates in special (cluster and/or global) initiatives as they relate to quality and compliance outcomes
May assume additional responsibilities or special initiatives such as ' Quality/Compliance Champion', ''Compliance Subject Matter Expert' or 'Business Process Owner'.